20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 20-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04530838

2022-001146-38 (EudraCT Number)

B7471016

Details and patient eligibility

About

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Enrollment: 668 patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
• Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion criteria

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
• Major known congenital malformation or serious chronic disorder.
• History of microbiologically proven invasive disease caused by S pneumoniae.
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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668 participants in 3 patient groups

20-valent pneumococcal conjugate vaccine (subcutaneous)

Experimental group

Description:

20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)

Treatment:

Biological: 20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine (subcutaneous)

Active Comparator group

Description:

13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine (intramuscular)

Experimental group

Description:

20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)

Treatment:

Biological: 20-valent pneumococcal conjugate vaccine